investigation of the safety and tolerability of bsct (anti-nf-p2x7) 10% ointment

Conditions: Carcinoma, Basal Cell (BCC)

Summary: this is a phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of bsct (anti-nf-p2x7) 10% ointment in subjects with bcc.

the purpose of the trial was to determine the safety and tolerability of bsct (anti-nf-p2x7) 10% ointment topically applied twice daily for 28 consecutive days in male and female patients with bcc; and to determine the steady-state pharmacokinetics (pk) of the active pharmaceutical ingredient (total sheep immunoglobulin g \[igg\]) when bsct (anti-nf-p2x7) 10% ointment is applied twice daily to bcc lesions. this was an open-label, single-arm, multicenter phase 1 study that enrolled 21 bcc patients.

Eligibility criteria:
inclusion criteria: * male or female adults ≥ 18 years of age; * one primary histologically confirmed bcc lesion, not located on the hand or foot, suitable for surgical excision, with a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (histological diagnosis made no more than 4 weeks prior to the screening visit. * willing to refrain from using non-approved lotions or creams on the bcc treatment site and surrounding area during the treatment period and from washing the treated area for at least 8 hours following each application of study medication; * ability to follow study instructions and likely to complete all study requirements; * written informed consent obtained, including consent for biopsy tissue to be examined and stored by the central dermatopathologist; * written consent to allow photographs of the bcc lesion to be used as part of the study data; * for females of childbearing potential, a negative pregnancy test at screening and use of an acceptable form of birth control. exclusion criteria: * pregnant, lactating, or planning pregnancy during the study; * presence of known or suspected systemic cancer; * histological evidence of squamous cell carcinoma (scc) or any tumor other than bcc in the biopsy specimen; * histological evidence of severe squamous metaplasia, infiltrative, desmoplastic, or micronodular growth patterns in the biopsy specimen; * evidence of dermatological disease or confounding skin condition within the 25-cm2 treatment area, eg, scc, actinic keratosis, rosacea, psoriasis, atopic dermatitis, eczema, or xeroderma pigmentosa; * concurrent disease or treatment that suppresses the immune system; * chronic medical condition that in the judgment of the investigator would interfere with the performance of the study or would place the patient at undue risk; * known sensitivity to any of the ingredients in the study medication; * treatment with systemic chemotherapeutic agents (eg, methotrexate, paclitaxel) within the 6 months prior to the baseline visit; * use of systemic retinoids within the 6 months prior to the baseline visit; * treatment with systemic immunomodulators or immunosuppressants within the 6 months prior to the baseline visit; * use of topical immunomodulators within 2 cm of the target treatment area within the 4 weeks prior to the baseline visit; * treatment with topical agents for the treatment of bcc or actinic keratosis within 2 cm of the target treatment area within the 4 weeks prior to the baseline visit: * treatment with liquid nitrogen, surgical excision or curettage within 2 cm of the target treatment area during the 4 weeks prior to the baseline visit; * clinically significant abnormalities as noted in the screening ecg, physical examination, or laboratory test results; * evidence of current chronic alcohol or drug abuse which, in the investigator's opinion, might interfere with the subject's adherence to protocol requirements; * current enrollment in an investigational drug or device study or participation in such a study within 4 weeks of the baseline visit; * in the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions of the protocol and complete the study.